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510(k) Data Aggregation
K Number
K170902Device Name
Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit
Manufacturer
SPR Therapeutics, LLC
Date Cleared
2017-06-26
(90 days)
Product Code
NHI
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SPR Therapeutics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days in the back and/or extremities for:
- · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
- · Symptomatic relief of post-traumatic pain;
- · Symptomatic relief of post-operative pain.
The SPRINT PNS System is not intended to treat pain in the craniofacial region.
Device Description
The Sprint PNS System is comprised of a percutaneous electrode placed via an introducer needle in proximity to a target peripheral nerve associated with a painful area and a wearable external stimulator that delivers stimulation therapy to the percutaneous electrode. The Sprint PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted through the skin via an introducer needle and remain indwelling for the duration of the therapy (up to 60 days).
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K Number
K161154Device Name
Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs
Manufacturer
SPR THERAPEUTICS, LLC
Date Cleared
2016-07-23
(89 days)
Product Code
NHI
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SPR THERAPEUTICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Smartpatch Peripheral Nerve Stimulation (PNS) System is indicated for up to 30 days in the back and/or extremities for:
- · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
- · Symptomatic relief of post-traumatic pain;
- · Symptomatic relief of post-operative pain.
The Smartpatch PNS System is not intended to treat pain in the craniofacial region.
Device Description
The Smartpatch PNS System is comprised of a percutaneous electrode placed via an introducer needle in proximity to a target peripheral nerve associated with a painful area and a wearable external stimulator that delivers stimulation therapy to the percutaneous electrode. The Smartpatch PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted through the skin via an introducer needle and remain indwelling for the duration of the therapy (up to 30 days). The diameter of the wire is 0.26mm. The wire is provided in two lengths (20cm, 40cm) with a maximum placement depth of approximately 10cm.
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